ACI’s 23rd FDA Boot Camp

July 30, 2014

The American Conference Institute’s popular FDA Boot Camp, now in its 23rd iteration, is slated to take place at the Omni Parker House Boston in Boston, MA from Thursday, September 18 to Friday, September 19, 2014. The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult terrain of FDA regulatory law.

The 23rd edition of the FDA Boot Camp will be co-chaired by Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst, and Arnold & Porter LLP’s Daniel A. Kracov. Attendees will be regaled by a stellar cast of presenters who will share their knowledge and provide critical insights on a host of topics, including:

The organization, jurisdiction, functions, and operations of FDA

The essentials of the approval process for drugs, biologics, and devices, including: INDs, NDAs, BLAs, OTC Approval, 510(k) submissions, and the PMA process

Clinical trials for drugs and biologics and the clearance process for devices

The classification of devices and the concept of “risk-based” classification

The role of the Hatch-Waxman Amendments in the patenting of drugs and biologics

Labeling in the drug and biologics approval process

cGMPs and other manufacturing concerns relative to products liability

Proactive adverse events monitoring and signal detection

Recalls, product withdrawals, and FDA oversight authority

FDA Law Blog is a conference media partner. As such, we can offer our readers a special $200 discount. The discount code is: FLB200. You can access the conference brochure and sign up for the event here. We look forward to seeing you at the conference.